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Kardigan · 15 hours ago

Senior Director, Clinical Operations Program Lead

Princeton, NJ

Full-time

Onsite

Director/Executive

$234K/yr - $305K/yr

12+ years exp

Kardigan is a heart health company dedicated to preventing and curing cardiovascular disease. The Senior Director, Clinical Operations Program Lead will oversee clinical studies for a late-stage cardiovascular asset, managing internal teams, CROs, and vendors to ensure successful execution of the clinical development plan.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

Responsibilities

Accountable for the delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

Develop and present the operational strategy and plans including supply chain to effectively execute on the Clinical Development Plan

Partner and collaborate with cross-functional stakeholders such as the Project Team Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders

Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Kardigan’s SOPs

Drive the selection, oversight, and management of CROs and other vendors

Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

Own the strategy and execution of creative approaches to achieve Kardigan’s corporate goals. This may include innovative solutions to digital patient-oriented data capture and storage, the development and deployment of novel clinical research platforms and approaches, and the pursuit of collaborations that will enhance progress of Kardigan’s research programs

Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

Lead and provide oversight to the trial-specific operations team including the CROs/vendor(s) to function effectively and cohesively

Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures

Along with other Clinical Development personnel, represent Kardigan’s externally to Investigators, site staff, and Key Opinion Leaders

Perform and document study level Sponsor Oversight of outsourced clinical activities

Communicate study-status, cost and issues to ensure timely decision-making by senior management

Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance

Lead and/or participate in Development Operations workstreams related to departmental and operating model related initiatives

Develop and foster strong, collaborative relationships with key stakeholders both within and external to Kardigan’s, including Prolaio

Directly manage assigned Clinical Trial Leads with a focus on performance, coaching and career development; provide mentorship to Site Operations Managers/Associates by providing clinical operations expertise and support identification and prioritization of study and program level work

Strive for continuous improvement and more efficient ways of working in clinical development

Qualification

Clinical trial managementCardiovascular disease studiesDrug developmentLeadership skillsICH/GCP complianceOperational strategyCross-functional collaborationInnovative mindsetCommunication skillsOrganizational skills

Required

Minimum of BA/BS with at least 12 years of global clinical trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience

Robust experience in early and late phase drug development; some late-stage development experience is required

Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc

Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc

Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

Experience in ICH/GCP inspections, audits and inspection preparedness

Outstanding communication skills, both verbal and written

Excellent organizational skills and ability to work independently

Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset